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    ACCU-BEAM TUBE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123298·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 200mm

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY

    IMMULITE 2000 MIXED ALLERGEN PANELS

    FDA 510(k)
    FDA Class 2 ·Immunology

    OBIX PERINATAL DATA SYSTEM 7.0

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 17, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 9, 2010

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·July 9, 2014

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    FDA Adverse Event
    Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code KNS·October 1, 2025

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012